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CTRI Number  CTRI/2024/07/071185 [Registered on: 24/07/2024] Trial Registered Prospectively
Last Modified On: 23/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To identify blood based biomarker to predict lupus flare using molecular and protein marker  
Scientific Title of Study   An integrated transcriptomics and proteomics approach for identification of altered plasma miRNA and blood proteins as composite biomarker panel in lupus flare 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mukhyaprana M Prabhu 
Designation  Professor and Head 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of General Medicine KMC Manipal
Kasturba Medical College, Manipal Department of Medicine
Udupi
KARNATAKA
576104
India 
Phone  09632118700  
Fax    
Email  mm.prahu@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Abhibroto Karmakar 
Designation  PhD Scholar, Department of General Medicine KMC Manipal 
Affiliation  Kasturba Medical College ,Manipal 
Address  Kasturba Medical College, Manipal Department of Medicine

Udupi
KARNATAKA
576104
India 
Phone  09051469974  
Fax    
Email  abhibroto.karmakar@learner.manipal.edu  
 
Details of Contact Person
Public Query  
Name  Abhibroto Karmakar 
Designation  PhD Scholar 
Affiliation  Kasturba Medical College ,Manipal 
Address  Kasturba Medical College, Manipal Department of Medicine
Kasturba Medical College, Manipal Department of Medicine
Udupi
KARNATAKA
576104
India 
Phone  09051469974  
Fax    
Email  abhibroto.karmakar@learner.manipal.edu  
 
Source of Monetary or Material Support  
Indian Rheumatology Association Regd Office: D-110, Defence Colony, New Delhi – 110024 
 
Primary Sponsor  
Name  Indian Rheumatology Association 
Address  Indian Rheumatology Association D-110,Defence Colony, New Delhi-110024 
Type of Sponsor  Other [Rheumatology Society India] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrSubhradip Karmakar  ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI  Lab No-3018, Dept. of Biochemistry
New Delhi
DELHI 		 9650745589

subhradipaiims@gmail.com 
Dr MUKHYAPRANA M PRABHU  KASTURBA MEDICAL COLLEGE MANIPAL  Department of Medicine B wing, room number 2010
Udupi
KARNATAKA 		 09632118700

mm.prahu@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE ALL INDIA INSTITUTE OF MEDICAL SCIENCES  Approved 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M048||Other autoinflammatory syndromes,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  SLE patients with mild or severe flare
Patients conformed to the SLE classification criteria by the 2019 EULAR/ACR classification
Female or male above 18 years 
 
ExclusionCriteria 
Details  Pregnant women
Malignant Patients
Patients with other autoimmune disease
Patients with comorbidities 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To develop miRNA characterization and blood proteomics profiles in lupus at different disease activities.
2. The targeted miRNA-protein pathway will be used to develop novel targeted therapy for lupus 		 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
Identifying specific miRNA and protein-specific pathways from the blood cell will help in screening and early diagnosis, as well as a novel way to monitor precision therapy.  12 months 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/09/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response (Others) -  Experimental data procured from the study.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (Yes).

  6. For how long will this data be available start date provided 15-10-2024 and end date provided 15-10-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Systemic lupus erythematosus (SLE) is a chronic, heterogeneous, systemic autoimmune disease characterized by autoantibody production, complement activation, and immune complex deposition. It predominantly affects young and middle-aged, child-bearing women. Despite many attempts performed to comprehend the pathogenesis of SLE, there is still a deficiency of adequate knowledge about the precise mechanisms underlying the disease to develop effective therapies for SLE patients. micro-RNAs(miRNAs) have been implicated in the development of SLE by the recent studies. Genetic and environmental factor plays an important role in leading SLE. miRNA dysfunction leads to autoimmunity. miRNA-mediated B cell and T cells lead to SLE pathogenies. Distinct miRNAs are differentially expressed in both SLE mice models and human patients. miRNAs are important targeting molecules modulating susceptibility to SLE. Micro-RNAs are small, non-coding RNAs regulating gene expression at transcriptional and translation levels. They play a crucial role in the development of the immune system and as the regulator of both the innate and adaptive immune systems. Considering this, miRNAs have become an area of interest owing to their contributory role in disease pathogenesis. In SLE, there is an activation of both the innate and adaptive immune systems and specific miRNAs are linked to some key processes involving both. With the new insights about miRNA’s involvement in SLE, studies have determined the differential expression in SLE. Most of the profiling studies have been done on Caucasian an Asian differently expressed miRNA in plasma, serum and urine has been seen in different states of disease in lupus. 
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